Distributed medication delivery using autonomous delivery device

ABSTRACT

A pump operations module having a base function includes only base function programming in the module itself but is configured to autonomously execute advanced delivery programs stored in its buffer. An advanced interface module (AIM) is used to prepare the advanced delivery programs and upload them to the pump operations module as well as monitor the performance of those modules. However, the advanced interface module does not control the execution of those advanced delivery programs by the pump operations modules. In the event that the patient&#39;s condition requires a change in the present advanced delivery program, the AIM is used to create a revised advanced delivery program and upload it to the pump for storing and executing from the pump&#39;s buffer memory.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.14/808,928, filed Jul. 24, 2015, now U.S. Pat. No. 10,149,938, which isa division of U.S. application Ser. No. 13/528,758, filed on Jun. 20,2012, now U.S. Pat. No. 9,089,642, which claims the benefit of U.S.Provisional Application No. 61/499,091, filed Jun. 20, 2011, all ofwhich are incorporated by reference herein.

BACKGROUND

The invention relates to control over medical delivery devices and moreparticularly, to medical delivery systems and methods havingsafety-enhancing configurations designed to lessen the effects ofprocessor control errors.

Infusion pumps are in widespread use in the medical field. Numeroustypes of infusion pumps and infusion pump systems are known in the art.Infusion pumps have been designed with the base functions of a deliveryrate and a volume-to-be-infused (“VTBI”) (or delivery time and totaldose). Over the years as processors have evolved with increasedcapability, faster speeds, and reduced cost, infusion pumps, as well asmany other medical devices that deliver medical treatment to patients,have incorporated these processors and have become more complex withmany more features made available. Very complex medication deliveryprofiles can be programmed into such pumps for the care and treatment ofpatients. Doctors, nurses, and technicians who are trained to programand use the complex features are often referred to as “super users.”Such super users are able to program such pumps with very complex fluiddelivery programs, and in some cases, configure them for specific use inparticular wards of hospitals or other healthcare institutions.

Many of these advanced infusion pumps may be used in different pumpingmodes as the infusion pump may include several embedded programs toenable different operational modes. In the environment of intensive careunits, cardiac care units, operating rooms, or trauma centers, it isoften necessary to infuse into the patient one to eight different drugssimultaneously. In addition, some of the drugs used in theseenvironments are not directly compatible with each other and thereforeneed to be infused into the patient at different points of the body.Such multiple infusions at different patient delivery sites requiredifferent pumping “channels” or pumping modules. In addition, it isfrequently necessary to observe and recall the condition of the patientat certain intervals or to adjust the medication in accordance with thepatient's reaction to it. To do so, changes to the pumping program ofone channel may need to be made without disturbing drug delivery ordevice operation of other channels. In addition, in order to be able torecall patient conditions, large amounts of patient data must be storedand access to and manipulation of that data must be made availablewithout disturbing any ongoing pumping processes.

In some cases, a modular programmable patient care system is used thatcomprises an apparatus for centrally interfacing with a plurality ofconnected functional devices that provide patient medication infusionsand patient monitoring. The number of pumping modules, the complexity ofthe infusion programs that can be applied for each one, each program ofwhich may differ from the others, and the number and complexity ofpatient monitors can generate a large amount of data for a centralcontroller to process, and in some cases, can cause data programming andmonitoring overloads. Even with single channel devices, the complexityof monitoring and controlling the device has created a time managementissue when the user interface is added to the activities beingcontrolled and responded to by the processor. Adding multiple channelsjust increases the probability of time management issues.

Such systems containing multiple infusion pumping devices are known inthe medical field and are a natural response to the need for multiplepumps on a single patient. For example, U.S. Pat. No. 4,756,706 to Kernset al. discloses a centrally-managed infusion pump system in which pumpand monitoring modules are attached to a central management unit (CMU)or central controller. The central management unit controls the internalsetup and programming of each of the attached pump modules, and receivesand displays information from them.

U.S. Pat. No. 4,898,578 to Rubalcaba, Jr. also discloses a medicationinfusion system that includes a plurality of infusion pump modules thatmay selectively be attached to a central management unit or centralcontroller (CMU) so as to provide for centralized control. Inparticular, the CMU obtains infusion parameters from the user and thenperforms calculations with the parameters to establish the desiredinfusion rate at a designated attached pump module. Once this rate isdetermined, the central management unit controls the infusionaccordingly.

Turning now to FIG. 1, there is shown an existing medication deliverysystem 20 comprising a central management unit 22 (CMU), three infusionpumps 24, 26, and 28, and an oximeter 30, all of which are connectedwith and controlled by the CMU. All of the infusion pumps and theoximeter are connected with the same patient 32 in this example. All theforegoing devices 22, 24, 26, 28, and 30 are mounted to a floor stand 34having a stable base 36. Also mounted to the floor stand at its top is amedication hanger 38 from which three medication containers are hung 40,42, and 44. The right-most container 40 is connected with the top pump24 and the patient 32 through a fluid line 46, with the pumpcontrollably delivering the fluid of the container 40 to a firstdelivery site 47 at the patient. The middle container 42 is connectedwith the center pump 26 and the patient 32 at a different location, ordelivery site 49, than the top pump through a fluid line 48, with thepump controllably delivering the fluid of the container to the patient.The left-most container is connected with the bottom pump 28 and thepatient 32 through a fluid line 50 with the pump controllably deliveringthe fluid of the container to yet another delivery site 51 on thepatient. The oximeter 30 receives oximetry data from a sensor (notshown), located at the patient at a location 53, selected so at to sensethe necessary patient physiology, through a data line 52 for processing.

The CMU of FIG. 1 includes a user interface 58 comprising a display 60and a keypad 62. The CMU receives programming input through itsinterface 58 and provides real-time programming control over each of thepumps or channels 24, 26, and 28. The CMU provides instructions to eachof the pumps in real time to which they are responsive, it monitors thefunctional operation of each pump, and it monitors the operating timersof each pump and its respective processor. The CMU stores a drug librarythat is used both as a safety feature and a data base. The CMU monitorsthe delivery of each pump and updates instructions in real time to eachpump according to programming of the CMU and possibly in accordance withoximeter data. The CMU also responds to user data entry to updateinstructions to one or more of the pumps. The pumps are responsive inreal time to the updated instructions; i.e., they are under the directcontrol of the CMU. The CMU may or may not be connected with a remoteprocessor, such as a pharmacy server, or an administration servercentral to a healthcare facility.

In the centralized control systems discussed above, there are severaldisadvantages. For example, in these systems the central management unitmust be aware of and must control much of the functionality of theattached pump units. This can result in a large data processing load forthe CMU. Some systems include a single complex central management unit(CMU) that must be used to control and program multiple infusion pumps.Complex central management units having a high data processing load areundesirable in clinical situations due to the possibility that a dataoverload may occur in which the processor is unable to timely processall data and output instructions. In such a situation, the CMU typicallyshuts down and consequently, all pump modules are shut down since theyare under the direct control of the CMU. Shutdowns of the CMU and itspump modules can occur unpredictably with the result that the patientdoes not receive the medication at the desired time unless the systemcan be reset and restarted immediately or a replacement system can belocated and programmed immediately. The same shutdown can happen in asingle-channel pump where the processor becomes overwhelmed by complexprogramming and data processing requests.

Medication errors, that is errors that occur in the ordering,dispensing, and administration of medications, regardless of whetherthose errors cause injury or not, are a significant consideration in thedelivery of healthcare in the institutional setting. The Sep. 9, 2002issue of Archives of Internal Medicine reported a study indicating thatnearly one in every five doses of medicine given to patients in thetypical hospital is a medication error (“Medication Errors Observed inThirty-Six Health Care Facilities”). This study confirms the findingsfrom earlier reports, including the 1999 Institute of Medicine Report,which revealed that more than 50,000 deaths in the United Statesannually are the result of medication errors. Medication errors are theeighth leading cause of death in the United States. Additionally,adverse drug events (“ADE”) defined as injuries involving a drug thatrequire medical intervention, which are a subset of medication errors,represent some of the most serious medication errors, and areresponsible for a number of patient injuries and death.

Healthcare facilities continually search for ways to reduce theoccurrence and severity of medication errors. Various systems andmethods have been considered and developed at present to reduce thefrequency of occurrence and severity of preventable adverse drug events(“PADE”) and other medication errors.

Manufacturers have tried using various techniques to avoid infusionerrors, one of which includes the use of hand-held personal digitalassistants (“PDA”) that are designed to provide drug administrationscheduling, drug administration verification, and the electronicdocumentation of drug administration. These devices are predominantlyused to verify the administration of oral, intramuscular (“IM”),subcutaneous, and topical drugs and have limited capability in verifyingthe administration of intravenous (“IV”) drugs. PDAs have been found tobe useful for scheduling and perhaps monitoring, but can do very littleor nothing about data overload and shutdown of an infusion pump system.

Healthcare facilities continuously strive to provide quality patientcare and many steps have been taken to lessen the chances of such errorsoccurring. The possibility of medical errors, such as where the wrongpatient receives the wrong drug at the wrong time, in the wrong dosage,or even where the wrong surgery is performed, are a significant concernfor all healthcare facilities. Various solutions to these problems havebeen proposed, such as systems that use bar codes or RFID tags toidentify patients and medications, or systems allowing the beside entryof patient data. While these systems also have advanced the artsignificantly, infusion data processing and programming errors continueto be a problem. For example, even where the medication order includesthe correct infusion parameters and those parameters are correctlyentered into an infusion pump, a data overload of the pump's processoror a remote centralized processor may cause the pump to stopadministering the medication to the patient, thus causing a deliveryerror to the patient.

As briefly mentioned above, very complex pumping programs can begenerated in the care and treatment of patients. The ability to controlautomatically a pump to provide a complex medical delivery regimen orpattern can have a significant benefit for a patient. A medicationdelivery pattern can be designed to optimize delivery of a particularmedication that takes into account factors of the particular situation.Costs are lowered since the attention of nurses is not required eachtime a delivery parameter of the pump must be changed—it is doneautomatically. Although conventional drug infusion controllers havegreatly improved the efficiency and ease with which medications aredelivered to a patient, complex pumping programs, and the data producedfrom them, can reach the limits of certain processors. Data overloadsare possible and their occurrence is not predictable. In some areas ofmedication delivery, even higher levels of data and instructionprocessing are necessary. The processor is “highly” taxed and whenmultiple requests are made of the device, changing delivery parametersoccur, complex algorithms are running, single fault failure timing is inplace, etc., devices on the market are shutting down without alarmconditions in some instances. The issue is the defined frequency ofmonitoring and control interface with the pump while also needing torecognize and respond to the user interface.

For example, certain pharmacokinetic models can require very complexinfusion programs. U.S. Pat. No. 5,010,473 to Jacobs discloses amodel-based open-loop process for controlling the concentration of adrug delivered intravenously to a patient as a function of the rate ofinfusion. A three-compartment pharmacokinetic (PK) model is used todetermine the plasma drug concentration. Such PK systems are attractivefor certain therapy, but require a large amount of programming, datamanipulation, and control. Based upon the linear relationship betweendata pairs comprising a rate of infusion and a corresponding plasma drugconcentration, an interpolated rate is determined by a microprocessor asa function of the specified plasma drug concentration. The actualinfusion rate of the drug during successive time intervals isrepetitively used to compute the plasma drug concentration at the end ofeach time interval. For each iteration, state variables from theprevious computation are applied to determine the next interpolatedinfusion rate. Open-loop medication delivery control methods can achievethe specified plasma drug concentration, but a relatively complexmedication delivery program is incorporated.

It will be apparent that controlling the administration of a pluralityof drugs through a multi-channel drug infusion system using a PK modelto predict the drug concentration and control the rate of infusion wouldrequire significant programming tasks over the prior art control of asingle channel. If desired, a different PK model could then beselectively applied to control the delivery of each different drugthrough each channel of a multi-channel drug delivery system, or thesame model could be used for the control of each channel of the system.

At times, a physician may find it necessary to alter briefly theparameters of a drug therapy. If the drug administration is beingcontrolled by a PK model, the physician may want to switch to a manualmode for a period of time, for example, to administer a bolus dose. Itshould thereafter be possible to switch back to the PK model controlledmode. Accordingly, it is important that the control for a pump that isused to administer drugs in accordance with a PK model be able to trackthe history of the drug administered and take into consideration changesthat occur while the PK model controlled mode is interrupted by a manualcontrolled mode, when the PK model control mode resumes. Since thehistory of the blood plasma concentration must be retained to achievethis goal, the infusion system control should be able to display bothhistorical and predicted blood plasma and compartment effect drugconcentrations levels to medical personnel for each drug administered,during either model controlled or manual controlled modes of operation.The model should continue to track and display these parameters, evenafter the drug infusion has stopped, so long as the patient's case isactive. If all the above is performed by an infusion pump, or by asystem of pumps with a central controller, significant data processingloads can occur for the processor or processors involved. Should suchdata loads exceed the processor's capability, a shut-down may occur andthe therapy could be delayed.

It has been recognized that infusion pump designs currently on themarket present potential safety issues. This may best be demonstrated bythe fact that the U.S. Food and Drug Administration (“FDA”) issued aproposed Infusion Pump Improvement Initiative on Apr. 22, 2010. Theirjustification for the initiative is that the number of recalls andpotentially understated number of safety events involving infusion pumpsare too high.

Observations:

The following observations are made after a review of FDA Medical DeviceReports (“MDRs”), details provided with infusion pump recalls, andassessment of human factors known to exist in health care facilities.

During pump operation, software, hardware, and the user interface makemajor contributions to reported causes of pump recalls.

-   -   A. The intravenous (IV) infusion pump hardware/software        interface uses a master/slave model where the master process        controller, or “master processor,” is the master for multiple        channels. The master/slave relationship mandates that the pump        channel operate only when the master control module or processor        is functioning properly. This master/slave model can result in        conflicts between the master processor's need to perform        specific system checks and the user's demand for the master        processor to process instructions being provided by the user.        The processor as the master requires that the pump performance        be interrupted if a processor or control module failure occurs.    -   B. To clarify the above problem through a comparison to another        high data load system, video game programmers are faced with the        same problem in that as the console game program begins to        utilize too high a percentage of the processor's capacity, the        “super user” begins to see slight delays in the video updates        (for example, characters begin to freeze in place on the        screen). The same is true with IV infusion pumps. The exception        is that with the IV pump, the super user sees an error code or a        potential programming error. The significant number of recalls        associated with this design approach has been used as part of        the FDA Infusion Pump Improvement Initiative.

Complexities of pump programming are not supported with the userinterface screens provided with the feature-enhanced infusion pumpscurrently on the market.

Numerical keypads have a similar data entry error rate regardless of thestyle of keypad used. This added with the human factor of confirmationbias (humans tend to fail to check closely when asked to confirm)results in some level of over- or under-infusion of the solution (drug).

The advanced infusion pumps provide the users with the ability toprogram the pumps to address many different therapeutic procedures.However, the same feature enhancements require the user to program thepump while advancing through a series of screens. Each screen may usethe same key as previously used for a different purpose. The potentialerrors associated with multiple functions for the same key potentiallyincrease the error rates experienced as practitioners move from onepatient population to another.

Infusion pumps are designed to address all of the needs in thehealthcare facility; i.e., they have the ability to pump a wide range ofvolumes. This increases the pump's ability to deliver significantly morefluids than reasonably logical to neonatal patients and also allowsdeliveries so small that the delivery rates are not clinicallysignificant for large adult patients.

The infusion pumps do not support easy readability during operation.This is especially true when multiple channels are operating and anerror condition is detected. Alarms sound and delivery stops or isaffected as a result of the error conditions. This condition is furthercomplicated when the practitioner attempts to clear the error conditionat the CMU and incorrectly takes action on channels not affected by theerror condition.

No infusion pump currently on the market known to the inventors wasdesigned to address the specific needs of anesthesia.

No infusion pump currently on the market addresses the specific needs ofthe neonatal intensive care patient population. Specifically, the drugdilution of many drugs being delivered at the same time may actuallyrequire the neonatal patient to receive more total fluids than istherapeutically beneficial to the patient.

Hence those skilled in the art have recognized a need for safermedication delivery devices. A need has also been recognized for amedical delivery device that is not susceptible to terminating deliveryof a medication in the event that a remote processor that is controllingdelivery ceases functioning properly. An additional need has beenrecognized for a medical device that is capable of receiving andoperating under a complex medication delivery program. Another need hasbeen recognized for safer data input devices and methods so that fewermistakes are made when inputting data related to medication delivery.The invention fulfills these needs and others.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the present invention is directed to amedical delivery device having a base delivery function with thecapability to run advanced delivery programs autonomously.

In particular, there is provided a system for the delivery ofmedication, the system comprising a medical delivery operations modulehaving a base function of medication delivery, the medical deliveryoperations module comprising a delivery mechanism, a user interface, abuffer memory, a communications system, an operations module processor,and a base function control program stored in a non-volatile memory thatis configured to program the medical delivery operations module for thebase function, wherein the communications system is configured toreceive an advanced medication delivery program from a source outsidethe medical delivery operations module and store the advanced program inthe buffer memory, and wherein the operations module processor isprogrammed to access the buffer memory and when the advanced medicationdelivery program has been completely loaded into the buffer, to executethe advanced medication delivery program autonomously.

In accordance with more detailed aspects, the operation module processoris further programmed to override execution of an executing advancedmedication delivery program by receiving a STOP signal from the userinterface. The advanced medication delivery program stored in the buffermemory comprises a sequence of varying base function operations that maybe performed one at a time, with the operations module processor beingprogrammed to access the buffer memory to retrieve a base functionoperation after an earlier one has been executed.

In yet further aspects, the medication delivery system further comprisesan advanced interface module (“AIM”) configured to create advancedmedication delivery programs, the AIM comprising an input device, adisplay, a medication delivery library containing delivery parametersand acceptable values for medications, and an AIM processor configuredto prepare an advanced medication delivery program including varyingbase functions.

In other detailed aspects, the display of the AIM includes a graphicaltouch screen, wherein the AIM processor is further programmed to displayan acceptable range of values for a selected medication on the touchscreen and accept a touch of a user to select a particular value in therange. The graphical touch screen displays slide controls for parametersrelated to an accessed delivery parameter from the medication library,and receives movement of a cursor within the slide control to select avalue for the medication. The advanced interface module is located in ahousing that is separate from the medication delivery operations module,although in another aspect, the advanced interface module is located ina housing that also contains the medication delivery operations module.

In more aspects in accordance with the invention, the operationsprocessor is programmed to ignore control data from outside themedication delivery operations module when the operations processor isexecuting an advanced program.

In method aspects in accordance with the invention, there is provided amethod for the delivery of medication, the method comprising programminga processor of a medication delivery operations module to perform a basefunction of the operations module, programming the operations moduleprocessor to check a buffer memory for the existence of a completeadvanced medication delivery program, upon finding a complete advancedmedication delivery program existing in the buffer, executing theadvanced delivery program on the delivery operations moduleautonomously, and ignoring control signals received from an externalsource during the execution of the advanced delivery program.

In more detailed method aspects, the method further comprises overridingexecution of an advanced medication delivery program upon receiving aSTOP signal from a user interface of the operations module. The methodfurther comprises preparing an advanced medication delivery program inan advanced interface module that is separate from the operationsmodule, wherein preparing the advanced program comprises assembling asequence of varying base function operations.

In yet other detailed method aspects, the delivery method furthercomprises displaying a graphical image of a range of values from whichan operator may select a value for preparing the advanced program. Thedisplayed range of values is retrieved from a library of acceptablevalues for a particular medication. The medical delivery method alsocomprises the step of displaying a cursor within the range of acceptablevalues, and programming the cursor to be movable to a selected positionwithin the acceptable range by the touch of a user.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of a prior fluid delivery and patient monitoring systemin which a central management unit (CMU) controls the operation of aplurality of medical devices, three of which are infusion pumps and oneof which is a patient physiological parameter monitor (oximeter), andreceives data from all four, the CMU also having a user interfaceincluding a keypad that allows control and data inputs for programmingeach device, and having a display to view the performance of eachcontrolled device and data produced by each;

FIG. 2 is an exemplary infusion pump system shown operating on adelivery tube to move medical fluid from a container to a patient, thepump system having a touch-screen interface that permits control anddata entry and displays data, a keypad input device, a peristalticpumping mechanism, and sensors in this embodiment;

FIG. 3 is an overview block diagram of an advanced interface moduleconnected with a pump operations module in which the two arecommunicating;

FIG. 4 is a block diagram of an intravenous (IV) infusion system inaccordance with aspects of the invention in which the embeddedoperational program in the pump's memory is limited to controlling onlythe base function of the pump; i.e., rate of delivery and volume to bedelivered, and showing a buffer memory into which a remote processor,such as an advanced interface module, uploads advanced delivery programsfor use by the pump's integral processor to vary the delivery rate andvolume to be infused in a more complex manner;

FIG. 5 is a block diagram showing an infusion pump receiving an uploadof an advanced delivery program from an advanced interface module (AIM),and the AIM also being configured to monitor the performance of the pumpin executing the uploaded program;

FIG. 6 shows an advanced interface module (AIM) having a graphical inputfor entering control data or other data, this graphical input being inthe form of touch screen slider controls in which a range is providedwith a cursor located within the range and moveable between one end ofthe range and another end of the range, the touch screen feature in thisembodiment allowing for direct movement of the displayed cursor betweenmaximum and minimum limits placed on the screen at respective ends ofthe range by access to drug libraries and patient population parameters,all selectable at the AIM, also showing the AIM connected with aninfusion pump and an external processor, that may be with a healthcareinstitution, pharmacy, medical records storage service, or other;

FIG. 7 is a block diagram of a single AIM connected with four separateinfusion pumps, that may all be connected to the same patient, foruploading advanced delivery programs to each pump as needed, and forproviding a monitoring interface for all of the pumps at a singlelocation, that may be selectable between each pump in one embodiment,and showing connection to an external server that may include ahealthcare institution's pharmacy server or other; and

FIG. 8 is a block diagram of a pharmacokinetic system incorporatingaspects of the invention in which three infusion pumps are used on thesame patient, along with a switch device to switch control over each ofthe pumps to a manual mode or to an advanced delivery program, and a PKmodeling and prediction portion that monitors the operation of each ofthe pumps to predict the necessary PK levels, all under user controls.

These and other advantages of the invention will become apparent fromthe following more detailed description when taken in conjunction withthe accompanying drawings of illustrative embodiments.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now in further detail to the drawings in which like referencenumerals are used to refer to like or corresponding elements among theseveral figures, there is generally shown in FIG. 2 an infusion pumpsystem 70. In particular, the pump system includes a peristaltic pumpmechanism 72 for moving fluid 74 through a delivery tube 76 from anupstream end 78 of the tube to a downstream end 80. In this case, thedelivery tube 76 interconnects a fluid container 82 with a patient 84.The base function of the infusion pump system 70 is to move controllablya certain amount of the fluid (volume to be infused or “VTBI”) from thecontainer to the patient. The pump system 70 may also include additionalsafety features that may or may not be mandated by governmentalregulatory agencies. In this case, a pressure sensor 86 and anair-in-line sensor 88 are included.

The pressure sensor and air-in-line sensor are not shown or describedherein in any further detail since such devices are well known to thoseof ordinary skill in the art. Similarly, the peristaltic mechanism isnot shown or described in any further detail since it likewise is wellknown to those of ordinary skill in the art. Other safety devices may berequired beyond those shown here, and other pumping mechanisms may beused to move the fluid from the container to the patient; a peristalticmechanism is merely shown as an example and no limitation of theinvention is implied.

In FIG. 2, the pumping system 70 is included in a single housing 90.Further included in the housing as part of the pumping system is a userinterface 100. In this case, the user interface comprises a keypad 102having certain keys for use in providing data and control of the pump,and a visual display 104. The display may also have touch screencapability so that it not only functions as a visual output device, butalso functions as an input device. In that regard, items displayed onthe display screen can operate as keys and be selected or activated bytouching them on the screen. The keypad 102 may also be a part of thedisplay 104 in that the keys may be “soft” keys displayed on the touchscreen 104 which are selectable by merely touching them. In a differentembodiment, the keys of the keypad may be hardware keys that arepressure sensitive, which are also well known in the art. Such devicesare also well known and no further details of their construction oroperation are presented here.

The touch screen display 104 of FIG. 2 shows the selectable keys of“Start”, “Date”, and “Time”, “Volume To Be Infused”, and “DeliveryRate”. Activation of the “Start” key is meant to instruct the pump tobegin pumping. Once started, the “Start” key is replaced by a “Stop” keyin this embodiment. The selection of the “Stop” soft key would result inthe pump stopping its pumping action. The “Date and Time” key whenactivated (“activated,” “selected,” “touched,” and “pressed” are usedinterchangeably herein) permits the user to update the correct date andtime in the pump's memory for use in time stamping the recordsestablished in the pump's internal log of the medication deliveries itmakes. Also, having an internal clock enables advanced time-basedprogramming of the pump so that complex fluid delivery programs may beused. The two base function parameters of “Volume To Be Infused” and“Delivery Rate” comprise the programming instructions of the basefunction of the pump; i.e., base function programming. Additionalinformation such as patient identification, drug identification, as wellas other data may also be displayed.

Based on the observations recited above in the Background section, thebase function of an infusion pump is to controllably deliver a solutionat a specified delivery rate and at a total volume to be infused. Whilethere is a need to be able to prime or flush the medication delivery set(tubing, valves, cannula, and other items in the delivery path of themedication to the patient) so that air is purged before delivery, thisis a maintenance function separate from the base function. Typically,infusion pumps have a preprogrammed “prime” feature under which the pumpruns at a preselected rate to move fluid completely through the infusionset to purge air. This is a “hard” programmed feature and in some cases,changes to it cannot be made.

Other maintenance or basic input and output system (“BIOS”) functionsare keypad communications, video control over the display, powercontrol, communications controls, and others. These are not meant to beincluded in the “base function” of the device since they are common tomany processors. Instead the “base function” of the device is intendedto relate to the purpose of the existence of the medical device, such aspumping medication, providing pressurized gas for respiration, pumpingnutritional substances, etc.

As discussed in some detail above in the Background section, havingmultiple pumping channels controlled by a single central processor thatis controlling each pump to deliver under an advanced delivery programthat is executing in the central processor increases the probabilitythat the software, hardware, user interface interaction, and timingrequirements will be in conflict and result in an error condition. Inaccordance with an aspect of the invention, a medication delivery deviceis not controlled by a separate processor running an advanced deliveryprogram.

A base function program is typically stored in a non-volatile memorysuch as a read-only-memory or flash memory or other, and has a fixed setof programmable functions, that respond in real time. This is incontrast to an “advanced delivery program” that typically hasinstructions going beyond a simple base function program, although itmay be no more than controlling a series of base functions havingdifferent or changing parameter sets. An advanced delivery program istypically placed in a volatile memory. Such base function programscontrol the base function of the medical delivery device when it isstarted up and automatically assume operational control over that basefunction or functions. As an example, the base function program of aninfusion pump may be placed in a ROM or EEPROM, or other type of ROM orre-writable ROM, that is non-volatile, and controls the base function ofthe infusion pump; i.e., delivery rate and VTBI. There may be otherprograms but they will generally have control over maintenance orperipheral functions of the pump and do not directly affect the deliveryrate or volume to be infused. An advanced program in today's systems istypically run on a CMU which controls the pump in real time inaccordance with that advanced program.

In accordance with the above aspect of the invention, there is provideda medical device, the operation of which is defined in terms of basefunction of the device.

-   -   Example 1: the base function of an infusion pump is “Volume To        Be Infused” (VTBI) and at what “Delivery Rate.” All advanced        programming of an infusion pump is a function of VTBI and        delivery rate with the ability to determine the timing of when        to start delivery.    -   Example 2: the base function of a ventilator is “Volume To Be        Delivered” (VTBD) and “Frequency.” All advanced programming of a        ventilator is a function of VTBD and frequency with the ability        to determine the timing of when to start based on patient        response. (Note: VTBD may be defined as absolute volume, if the        ventilator is used to assist the patient, when patient breath        equals or exceeds volume to be delivered, the ventilator does        not cycle. In its base operation therefore, the ventilator did        deliver a specified volume as a result of delivery resulting        from patient activity.)

The basic premise to the above is that the delivery system can be brokendown into a series of base function deliveries. The complex or advancedprograms are merely a series of the base function carried out in aspecified order. As used herein, the term “medicine” or “medication” ismeant to be used in its broadest sense. That is, it includes any drug orremedy, including medicaments, air or other gases, food, and may includeothers.

In accordance with an aspect of the invention, the medical deliverydevice has no advanced programming embedded in the medical deviceitself; only the programming to implement the base function of themedical device is permanent. Furthermore, the integral local controllerof the medical device operates autonomously and is not configured tooperate under any direct external real time control by a remoteprocessor (such as an advanced interface module “AIM”). Referring now toFIG. 3, even if an AIM 160 is connected with the medical delivery devicesuch as the pump operations module 70 in this case, that AIM is not ableto exert any real-time operational control over the medical deliverydevice. The AIM may be able to collect data in real time from themedical device or check the status of a medication delivery to a patientin real time, but cannot directly control the medical device in realtime. Furthermore, the front panel programming of the medical device islimited to control over the base function of that particular medicaldevice but does not enable the user to create an advanced complexdelivery program for the medical device. In the example of an infusionpump, the front panel is used only to program the delivery rate and theVTBI; it cannot be used to write a complex delivery program, such asthat described below. However, in accordance with another aspectdiscussed below, advanced programming of the integral processor of themedical device can be indirectly effected from an outside source.

Now referring to FIGS. 2, 3, and 4, in the case of an infusion pumpoperations module 70, a buffer memory 120 is included that is largeenough to receive and store advanced delivery programs. The integrallocal processor 122 is programmed to access the buffer memoryperiodically and if a complete advanced delivery program is found there,the local processor will execute that program autonomously. Byautonomously, it is meant that the integral local processor 122 executesthe program on its own without being under the real time control of, ordependence on, a remote processor such as the AIM 160. While theintegral local processor 122 may also export status data to an externaldevice 124 including the AIM 160, or a remote server or processor ofanother type, the integral local processor 122 will carry out the buffermemory 120 advanced delivery program without accepting further inputfrom an external device. FIG. 3 presents an overview diagram of a systemand method in accordance with aspects of the invention. An advancedinterface module 160 is shown in which advance delivery programs may becreated, tested, and uploaded to a medication delivery device. In thiscase, a medication delivery device is shown, which is a pump operationsmodule 70. The pump operations module 70 includes a buffer memory 120for accepting advanced medication delivery programs from the AIM 160, aswell as other data and instructions, a processor 122 a pump mechanism72, and the pump's base function programming 130.

Execution of an advanced program may be stopped by the user pressing the“STOP” key on the front interface panel 100 of the pump 70 (FIG. 2). Atthat time, the user may continue to operate the pump from the frontpanel, to deliver a bolus for example. The user may also decide to goback to the advanced delivery program by pressing a CONTINUE key (notshown). Thus, an advanced delivery program can be overridden at any timefrom the front panel, but can be restarted also. As discussed below indetail, the ability to create such an advanced delivery program cannotbe done at the pump itself but instead, must be performed externally tothe pump and the program uploaded to the infusion pump operations modulebuffer memory 120.

In the infusion pump operations module 70 of FIGS. 3 and 4, a localprocessor 122 controls the operation of a peristaltic pump mechanism 72as to delivery rate and VTBI (base function). Sensors 128, such aspressure and air in line, are monitored by the local processor. Theprocessor is programmed by its base function program 130 that islocated, in this embodiment, in a read-only memory (ROM) 132 located inthe housing 90 of the pump operations module. The base function program130 could be an electrically erasable programmable read-only memory(EEPROM), or other non-volatile memory device, located by itself or withother memory devices in the pump system. The processor 122 also acceptscommands or instructions from various interface devices. An “InterfaceSTART” key 134 instructs the processor 122 to control the pumpingmechanism 72 to begin delivering fluid 74 to the patient 84 (see FIG.2). An “Interface STOP” key 136 instructs the processor to control thepumping mechanism to stop delivery of the fluid 74 to the patient 84.The “Interface RATE” key allows the user of the pump operations moduleto select a delivery rate, from which the processor will determine andcontrol the pumping mechanism to deliver controllably fluid to thepatient at the programmed rate. The “Interface VTBI” key allows the userof the pumping operations module to select a volume of fluid to bedelivered, from which the processor will determine and control thepumping mechanism to deliver controllably fluid to the patient until theprogrammed volume has been reached. The interface includes additionalfeatures 142 not discussed here in any detail, but which may includeconfirmation of a patient's name or other identification, user's name orother identification, etc. The pump operations module 70 also includes alog memory 144 in which the processor 122 stores pump events, such asprogrammed rate, VTBI, time of start, time of stop, sensor readings, andother data. All of the above are enclosed in a single housing 90 in thisembodiment as shown.

FIG. 5 presents a block diagram of a medical device (in this case aninfusion pump operations module 70 described above) connected with anAdvanced Interface Module (“AIM”) 160. The AIM and the pumpingoperations module may be interconnected 164 in this embodiment with ahardwired connection, optical, wireless, RF, or other or combination ofthese. The AIM, in this case, has a built in monitor 166 that can beused to monitor progress of fluid delivery by the pump, sensor readings,or other data generated by the pump system. It is shown as beingconnected by a separate data conductor 168, but this can also take otherforms, such as a wireless communication system as described above.Additionally, it may be a part of the connection 164 of the AIM 160 withthe pump operations module 70. It can also be used to view, but notchange, the delivery rate and VTBI of the pump operations module 70. Themonitor 166 is also usable to view the creation of an advanced deliveryprogram for upload to the pump operations module 70. In that regard, themonitor may have at least two modes; internal and external. It can alsobe used to monitor the upload of an advanced delivery program to thepump operations module. As will be discussed below, if a single AIM isin connection with multiple medical delivery devices simultaneously, themonitor 166 can switch between each for monitoring purposes or canpresent a “tile” view on a single screen of the data from multipledevices. Other presentations of data are possible.

An AIM 160 can comprise various computing devices. If its purpose is todo no more than prepare advanced delivery programs for infusion pumpoperations modules for example, many computers would function well. Ifthe AIM is needed to monitor the progress of the treatment provided by amedical device or plural medical devices, then the AIM may need certaindisplay configurations and software for processing, displaying, andrecording data signals. Many touch screen computers should functionefficiently in providing the advanced programming and monitoring screensfor several infusion pumps. Monitoring screens should provide theappearance and functional requirements of the “specific patientpopulation,” for example, neonatal, anesthesia, critical care,pediatric, emergency, and others.

In an aspect of the invention, a graphical input device is provided. Inone embodiment, a touch screen is used to display slide controls forsetting desired rates and VTBIs. A range is shown within which a cursormay be moved to select a “value” or “level.” The graphical slidecontrols are presented with the actual limits appropriate for therespective patient population in this embodiment. Neonate critical careverses adult fluid replenishment is an example in which the limits maybe quite different and the selection of the wrong key from a keypadcould result in incorrect drug delivery. Referring now to FIG. 6, thereis presented a limited example of the use of a graphical input device.An advanced interface module (AIM) 180 includes a touch screen 182 withwhich a user can create an advanced delivery program for upload to amedical infusion pump operations module or can monitor the performanceof an infusion pump, or both. In this case, the AIM has a second inputdevice of a keyboard 186. An external processor 188 may be connectedwith the AIM. Either the external processor or an internal AIM memorymay include patient population parameters 190 and drug libraries 192.See U.S. Pat. No. 5,681,285 to Alan D. Ford and Nathaniel M. Sims andMarc A. Mandro, incorporated herein by reference, for more detail ondrug libraries. The external processor may operate as only a memory inwhich data from the AIM 180 or its connected pumps or patient monitorsare communicated to be stored, analyzed, or other, or from which programand control instructions can be received.

In the case where drug libraries 192 are available to the AIM 180 andthey include predetermined limits on the drugs in the libraries forvarious patient populations, then selection of a particular patientpopulation 194 key on the touch screen 182 will enable the display ofthe drugs for that population as well as the limits for each drugspecifically designed for that population. For example, in FIG. 6, thedrug “Propofol” has been selected. The maximum and minimum delivery rateand VTBI are shown as graphical slide controls 196 and 198 respectively.In this case, the slide controls have a vertical orientation but inanother embodiment, they may have a horizontal orientation, or other. Atthe top of the slide controls are the maximum values for the drug and atthe bottoms are the minimum values.

In this embodiment, the touch screen 182 is used to display the slidecontrols and by simply using a finger to move the cursor or “slide” 200and 202 of each control, the values can be set. Because a keypad is notused, and the maximum cannot be exceeded for that patient populationwith this graphical slide control approach, it will be much moredifficult to make medication programming errors. The drug library willautomatically set the maximums and minimums for the particularmedication and the user is unable to change them. Additionally, using agraphical slide control shows the user a “relative” setting betweenmaximum and minimum. In many cases, a physician or nurse knows that thispatient is supposed to receive approximately an “average” dose of thedrug, and seeing that the slide falls about in the middle will reinforcethat the setting is correct in the mind of the user. If on the otherhand, the physician or nurse believes that the patient is to receive anaverage dose, but the slide is near the maximum value, a possible errorwill be made apparent. Thus common errors with striking the wrong key ona keypad are obviated.

In another feature shown on FIG. 6, the slide controls present apercentage value 204 and 206 somewhere near, on, or above the slide 200and 202. In the case of delivery rate in FIG. 6, the percentage isthirty-three and in the case of VTBI, the percentage is eighty-four. Inanother embodiment, an absolute number may be shown for the slidesetting rather than, or in addition to, a percentage.

The same graphical slide control approach can be used with an infusionpump operations module 70 that has a touch screen, with the samebenefits being realized. The use of such slide controls and druglibraries within a healthcare facility can prevent significantover/under infusions as a result of programming errors.

In another aspect where a plurality of infusion pump operations modulesare needed, touch screens can provide real-time pump operation status.In the event of a pump operations module or pump operations modulesexperiencing an alarm condition, the AIM screen can provide a clearindication of which pump operations modules are in an alert condition.Separation of advanced programming module from the pump operationsmodule and use of touch screen programming at the AIM to enable the useof advanced delivery programs ensures that programming controls do notnegatively affect a specific pump operations module and potentially leadto multiple pump operations modules going into alarm conditions. Tyingthe patient identification (“ID”) and the drug ID to the pump, andgraphical programming with touch screens support better drug deliverycontrols and appropriate security to ensure proper linkage between thepump operations modules and the advanced programming module.

The size of the screen should be selected to support user needs duringthe programming and continuous monitoring of the pump operation. If theAIM display is to be used to monitor a plurality of infusion pumps atonce, and a “tile” type of display is to be used in which a plurality oftiles, one for each pump, is to be displayed simultaneously so that allpumps can be monitored at once, the screen size of the AIM should belarge enough to accommodate the entire plurality of tiles so that theycan be seen clearly from a predetermined distance, perhaps three meters.

Much can be gained from the knowledge used in the development of videogames. A video game console is typically an interactive entertainmentcomputer or modified computer system that produces a video displaysignal that can be used with a display device, such as a high-definitionmonitor or a television, to display a video game. Typically, highquality audio is included that is played through the speakers of anaudio system or the television. The term “video game console” is used toindicate a machine designed for consumers to buy and use solely forplaying video games as opposed to a personal computer which has manyother functions. A console video game is typically an interactivemultimedia game used for entertainment. The game consists ofmanipulatable images and audio, sometimes very high quality andgenerating a three-dimensional type image, generated by a video gameconsole, and displayed on a television or similar audio-video system.The game itself is usually controlled and manipulated using a handhelddevice connected to the console called a controller, that generallycontains a number of buttons and directional controls each of which hasbeen assigned a purpose for interacting with and controlling the imageson the screen. The high quality and rapidly changing images, audiosynchronization, and a controller providing constant inputs can causeenormous amounts of data to be generated, that must be processed toavoid freezing images, crashes of the console, and other disablingeffects. Many approaches used in such an environment to keep everythingrunning smoothly can be adapted to the medical field as well.

Video console games require a much more advanced control of softwaredesign and operation than games designed to play on computers. Theconsole has very specific limitations of controller speed and memory.Therefore, the designers must recognize the limitations of thesoftware/hardware interface. At the same time the designers mustrecognize that the user interaction is expected to be as responsive asthe computer game. If the users' experiences are different, then theconsole game is not acceptable to be released to the market. Thetraditional pump design functions similarly to a game console with theprogram installed. The comparison to the game console is to show theeffect of processor speed and memory size impact on how complicated thegame can be. The system and method in accordance with the invention hasmoved a pump from a game console to the comparison with a printer, byremoving the advanced programming capabilities from the pump and addinga large buffer. The pump operates more like a printer receiving arequest to print multiple documents in a specific order. Bothcomparisons are provided to more clearly see the benefits. Embeddedadvanced programming with super users results in unexpected anomaliesand drug delivery issues. Providing a separate advanced interface modulededicates the pump operations module processor and memory to onlycontrolling the base drug delivery function. The complex algorithm userinterface (AIM) is isolated from the pump processor with the exceptionof the most basic programming. The paradigm shift is the move from thegame console model to a printer model.

In accordance with an aspect of the invention, the user can selectvalues for parameters of the base function of the medical deliverydevice without using an advanced interface module (AIM). For example, inthe case of an infusion pump operations module, the user can set adelivery rate and a VTBI from the front panel of the pump operationsmodule itself. In most cases this addresses the vast majority of themost common uses of the medical device. All medical device systemoperations, monitoring, and error notices are controlled by the deviceitself independent of an AIM. However, the medical device has buffermemory 120 (FIGS. 3 and 4) to accept and store user instructions sent toit from the AIM 160 (FIGS. 3 and 4). The medical device also has ahistory log 144 (FIG. 4) to maintain a record of activity and errorconditions. Medical devices designed to support only their base functionwill never require software updates to support new protocols or updateddrug libraries. Base medical device operation is the same for all userswhile such updates to protocols and drug libraries can be handled by theAIM alone.

The advanced interface module (AIM) has any number of advancedprogramming tools included in its user interface options. The AIM allowsthe user to program any number of base function instructions that, whenexecuted as specified, deliver the desired therapeutic outcome. Forexample,

-   -   delay the start for 10 minutes, then deliver a bolus of 20 ml in        2 minutes (VTBI=20 ml, rate=600 ml/hr),    -   then deliver 30 ml at 5 ml/hr,    -   then deliver bolus of 20 ml in 2 minutes (VTBI=20 ml, rate=600        ml/hr),    -   then deliver 30 ml at 5 ml/hr,    -   then deliver a bolus of 20 ml in 2 minutes (VTBI=20 ml, rate=600        ml/hr),    -   then deliver 30 ml at 5 ml/hr,    -   then deliver a bolus of 20 ml in 2 minutes (VTBI=20 ml, rate=600        ml/hr), and    -   then deliver 80 ml at 5 ml/hr, for a total delivery of 250 ml.

It must be understood that all advanced programming features require theuse of rate and volume to be infused, which are base functions. Theadvanced features then add delay starts, series of rate/volume to beinfused commands, and predetermined calculations that allow rate andtotal volume to be infused (VTBI) to be determined by specific patientdata and therapeutic outcomes.

In accordance with further aspects, an advanced interface module (AIM)provides a graphical representation of the proposed therapeutic deliveryschedule and the actual therapeutic delivery within ±24 hours. An AIMprovides visually enhanced status of each device programmed using theAIM. An AIM may be connected to the medical device in the followingmanner, direct wire, Wi-Fi, Bluetooth, optical, or RF. An AIM may beconnected to multiple medical devices, and is not limited to a singletype of device. Examples are infusion pump operations modules, an SPO₂monitor, an EKG monitor, and a ventilator. An AIM has the ability tocollect data from various monitoring devices and update scheduleddelivery based on patient response. Protocols where defined patientresponse dictates an increase or a decrease in delivery are examples ofthis capability; always per instruction of a physician or under specifichospital protocol. For example, 40% oxygen at 5 l/min until patientSPO₂≥95% for 2 hrs., reduce to 40% oxygen at 1 l/min, but if SPO₂drops≤92%, return to 5 l/min.

An advanced interface module (AIM) may be supplemented with predictivemodels to allow the user to optimize the therapeutic plan for thepatient, although medical practitioner interaction and verification isalways required. An AIM has touch screen capabilities and may allow amouse or a keyboard interface when appropriate or desired. An AIM'srecords are stored in files specific to individual patients and caninclude the drugs delivered, what each medical device was instructed todo, device data logs from start of therapy to removal from use on thepatient, patient identification, and additional information added bymedical personnel into a patient record. Further, an AIM's features maysupport formatting the stored data into patient records and sending themto the healthcare facility's patient records data archive, or elsewhere,such as an online Internet medical records storage service (Google™Health). An AIM also has the capability of automatically downloadingscheduled information into a facility's IT system as desired.

The advanced interface module can also take the form of a personalcomputer such as a laptop or tablet computer, or a personal dataassistant, or other device with which infusion pump programming can becreated. In the preferred embodiment, the advanced interface module 160has a separate housing from the infusion pump operations module 70 (seeFIG. 4).

It will be noted that there are significant paradigm shifts in theabove. In particular, advanced delivery programming features are notembedded in the infusion pump operations module. Separate touch screencomputers are used to control and support the advanced programmingfeatures required to provide healthcare-approved protocols in oneembodiment. The touch screen is developed to enable a user tointuitively program the advanced programming options that are madeavailable. In another embodiment, the communications could be wirelesswith a central touch screen at a nurse's station (or elsewhere) thatpermits a clinician to call up a patient. The delivery parameters wouldbe in place and they could be altered from a central panel, sendinginstructions to each pump at the bedside (similar to a wireless sharedprinter). If wireless communications could be safe enough, one couldeliminate having a touch screen connected to every device, and ratheruse a central touch screen that would wirelessly send commands to thedevices.

A programming touch screen located on an advanced interface module (AIM)in accordance with one aspect of the invention supports four to sixinfusion pumps assigned to a specific patient. The programming screensof the AIM are designed for specific patient populations and therapies,for example:

-   -   a. Anesthesia;    -   b. Critical Care:    -   c. Emergency;    -   d. Gene therapy;    -   e. General Care;    -   f. Neonatal Critical Care; and    -   g. Pediatric.

The programming touch screen of the AIM supports specific patientpopulation drug libraries, it supports patient identification (“ID”) anddrug ID, it supports specific patient therapy, it is capable ofcommunicating (one way initially) wirelessly with central data controlsystem(s), or other remote processors and data storage and processingfacilities. It supports advanced programming features by communicatingto specific patient-assigned pumps each delivering a specific drug. Thesoftware of the AIM and the programming touch screen may be upgradedwhen not in use with a medical device. Touch screen capabilities includegraphical slide control features for setting volumes and rates and thetouch screen supports patient monitoring status on the screen if desiredby a practitioner.

To briefly reiterate, the base function of an infusion pump operationsmodule in accordance with aspects of the invention is to deliver amedical fluid at a desired rate and total volume to the infused. Theinfusion pump operations module also provides a means to prime or flushthe system, the display screen is simple and provides rate, volume to beinfused, and total volume infused, the patient identification (ID) canbe entered or scanned, the drug identification (ID) can be entered orscanned, and a wired or wireless interface is provided between theinfusion pump operations module and an advanced interface (programming)module (AIM) having a touch screen. In an aspect in accordance withsecurity aspects of the invention, the patient ID is linked between thepump and the AIM through the AIM programming touch screen to ensure thatthe pump operations module is programmed by only one programming touchscreen at any given time. This is part of the system security to limitthe wireless communication of a programming touch screen to a singlepatient.

There is a need to deliver very small volumes to support developingtherapies and change the paradigm of drug use in the hospital. Currentlydrugs are controlled and distributed at multiple dilutions. This is acritical control point for the proper delivery of drugs to all patients.The multiple dilution options are required to support the drug use tomultiple patient populations. Heparin errors result when ahigher-than-ordered concentration is delivered to the neonatedepartment. The lower concentration is required because the infusionpumps currently on the market cannot deliver a single concentration ofheparin to all patient populations. Gene therapy is a developing therapythat requires the use of micro-liter (μl) units of measure. There areinfusion pumps approved for laboratory use but none for human therapyuse. Other than the size of syringes used and therefore the range ofdelivery rates and volumes, the requirements are the same. Disposablerequirements need to be developed to support the lower delivery ratesand volumes. The invention is applicable to syringe delivery, largevolume pump (LVP) delivery and others, and is not specific to anyparticular form of delivery, but rather addresses the buffer issuesneeded to have clear instruction execution.

By limiting the pump operations module to its base function of providingrate and total volume delivery with a system prime or flush option andmoving all advanced programming features to the touch screen of anadvanced interface module (AIM), the master/slave model currently usedin the intravenous pump industry is eliminated. The new model is moreappropriately defined as a general/soldier relationship. The individualpump (soldier) has control of its operation and performance and has itsown power source. The AIM programming touch screen (general) hasdetermined a strategy that is communicated to the pump when the pump hascompleted the current task. The AIM also has its own power source. Asoldier is told to take the hill and report back when the hill has beensecured. The general will then provide the next instruction to achievethe desired strategy. Similarly the AIM programming touch screencommunicates the first required rate and total volume to be delivered tothe buffer memory of the pump operations module. Once the delivery iscompleted by the pump operations module, the AIM programming touchscreen communicates the next required rate and total volume to bedelivered.

Each pump operations module is a stand-alone device that is capable ofaccepting a single rate of delivery and total volume to be infused. TheAIM has been loaded with capabilities that meet all the envisioned needsof the specific area of the hospital. The AIM interface is conductedseparate from the pumps when the AIM is used, and therefore, there is norisk of timing conflicts between the AIM and the pump operations module.The AIM is configured with effective human factor interfaces thatsupport intuitive programming and eliminate keypads for numeric dataentry.

Although FIG. 5 shows only one infusion pump operations module 70connected to an advanced interface module (AIM) 160, it is possible tohave a plurality of pump operations modules connected to the AIM. It isone of the advantages of the invention that the AIM can simultaneouslybe connected with a plurality of pump operations modules and otherdevices and can monitor all of them. The display screen of the AIM mayneed to be switched between each of the infusion operations modules formonitoring, or in another embodiment, the AIM's display screen may besplit into four quarters or other arrangements of multiple subscreens inwhich each quarter displays the monitoring data from a different pumpsystem. By being connected to a plurality of pump operations modules, anadvanced programming infusion routine prepared on the AIM can beuploaded to each pump operations module simultaneously. This could haveapplication where the delivery of drug interactions are established andestablished protocols have been loaded into the AIM, or to support nursestation updates when new patient orders are received via the electronicpatient record or other hospital communication tools.

Referring to FIG. 7, an embodiment of a system of a plurality ofinfusion pump operations modules 220, 222, 224, and 226 connected withan advanced interface module 230 is shown. The infusion pump operationsmodules may be the same as that shown in FIG. 3 or 4 or may havedifferent forms. Also, instead of all being infusion pump operationsmodules, one or more may be a different medical delivery device, such asan oximeter, ventilator, respirator, dialysis machine, enteric device,or other. The AIM includes a graphical input device, such as a touchscreen 232, and a second input device 234 which in this case comprises akeypad with which the individual digits of a level or value may bemanually entered sequentially. The invention is shown in which adedicated advanced interface module 230 (AIM) is shown that is connectedwith four pump systems 220, 222, 224, and 226. Although four pumpoperations modules are shown, an AIM may be able to connect with manymore at the same time, depending on the embodiment. The AIM may also beconnected with a remote processor such as a healthcare institution'spharmacy server, or other. In another embodiment, the AIM may be locatedin the same housing as the pump operations module. The AIM would beconfigured to provide advanced programming to the delivery device withinthe same housing. In yet a further embodiment, the co-located AIM mayalso be configured to output programming to other medical devices if putinto communication with them, such as by wired or wirelesscommunication. They may be outside the housing and may be remotedepending on the situation.

Pharmacokinetic System

As noted above, the advanced interface module (AIM) is configured toprogram selectively and monitor a plurality of drug delivery systems todeliver drugs in different modes. The delivery of drugs at a predefinedrate and volume, and delivery of a bolus dose are generallyconventional. However, the AIM is also able to deliver drugs through aplurality of drug channels (infusion pumps) in accordance with apharmacokinetic (PK) model. The PK model can be resident in an AIM andcan be used to program the rate of drug delivery to achieve either adesired blood plasma drug concentration of the drug within a patient'sbody, or a desired effect compartment drug concentration for the drug.

Briefly and in general terms, “pharmacokinetics” includes the study ofthe mechanisms of absorption and distribution of an administered drug,the rate at which a drug action begins and the duration of the effect,the chemical changes of the substance in the body, (for example byenzymes), and the effects and routes of excretion of the metabolites ofthe drug. Pharmacokinetics describes how the body affects a specificdrug after administration. Pharmacokinetic properties of drugs may beaffected by elements such as the site of administration and the dose ofadministered drug. These may affect the absorption rate. CompartmentalPK analysis uses kinetic models to describe and predict theconcentration-time curve.

A functional block diagram of a PK model 256 used by an AIM 180 inprogramming a plurality of pumps is shown in FIG. 8. As is described inmore detail below, the plurality of infusion pump operations modules250, 252, and 254 are programmed according to the role each one is tohave in carrying out the PK model. Since none of the pump operationsmodules have embedded advanced programming, the user has the option ofselecting either to control drug delivery at each pump operations modulein accordance with a PK model advanced delivery program uploaded to eachpump operations module, or alternatively, to administer a drug throughmanual control of the pump operations module, either as a bolus dose oras a continuous infusion at a selected rate. It is important to notethat control of the drug delivery rate in accordance with the PK modelcan be interrupted at any time, should the user switch to manual controlof the pump operations module to deliver a bolus dose or to provide aselected rate of continuous drug infusion. Delivery under the control ofthe PK model can then be selectively resumed.

This user-selective option for controlling the infusion of drugs isrepresented by a switch 260 in FIG. 7. In a first position 262, theswitch selects the infusion of drugs in accordance with manual control264 over the pump operations module, and in a second position 266, theswitch selects the infusion of drugs in accordance with the uploadedadvanced delivery program 268 consistent with the PK model 256.

Assuming that switch 260 has been selectively set by the user toadminister drugs in accordance with the PK model 256, the AIM 180uploads 268 an advanced PK delivery program to one or more of theinfusion pump operations modules 250, 252, and/or 254. Those programmedpump operations modules upon executing the advanced PK delivery program,set the rate of drug delivery to achieve either the desired blood plasmadrug concentration selected by the user, or the desired effectcompartment drug concentration. The source of these control signals isrepresented in FIG. 7 by the PK Model block 256. As further shown inFIG. 7, a user 270 may provide the user input to the PK model andprediction block 256 corresponding to a selected set point. Furthermore,the AIM monitors each of the infusion pump operations modules 250, 252,and 254 so that delivery data can be considered in the modeling andprediction.

The AIM 180 executes the PK simulation in block 256 to determine currentmodel data and the predicted drug concentration (blood plasma and/oreffect compartment) that are periodically supplied to the Upload PKProgramming block 268. Either type of drug concentration set point canbe changed 270 at any time and the PK model will provide a revisedadvanced PK delivery program for the administration of the drug toachieve the new set point. An update timer (not shown) establishes thetime interval at which the current model data and predicted drugconcentration are transferred from the PK modeling, prediction andsimulating in block 256 to the Upload PK Programming in block 268.

In accordance with a PK model controlled delivery, a desired set pointis achieved by controlling the multi-channel drug delivery system toattain the desired set point based upon a predicted drug concentrationwithin the patient produced by compliance with the model. The predictedconcentration of each drug administered by the multi-channel drugdelivery system is continuously modeled throughout an entire patientcase, regardless of: (a) the control mode that is selected, (b) anyinterruption of the drug delivery that may have occurred, or (c)termination of the drug delivery. The PK model control delivery can thusbe initiated at any time, interrupted, and then resumed. A first drugcan be administered through one drug channel 250 under the PK model 256by use of the manual mode 264 of a pump, a different second drug canthen be administered through that drug channel 250 also by use of themanual mode 264, and the administration of the first drug can be resumedthrough the same or a different drug channel through use of an advancedPK delivery program uploaded 268 to the first pump operations module250. Accordingly, even though only three drug channels are provided inthe multi-channel drug delivery system disclosed above, the AIM 180 cancontinue to track the predicted drug concentrations of substantiallymore than three drugs administered to the patient, and can createrevised programs for uploading 268 or indicate control over the deliveryof any of the drugs using the PK model control by manual mode 264 at anytime. Thus, a plurality of different drugs can be administered to apatient through any one or more of the drug channels, and PK control ofthe administration of any of those drugs can be selectively assumed bythe controller at any time during the patient case.

The PK simulation in block 256 models the blood plasma drugconcentration and/or effect compartment drug concentration of the drugbeing administered based upon variables that depend upon the specificdrug being infused, and patient specific data such as the weight, theage, and gender of the patient. Another important variable is the actualrate at which the multi-channel drug delivery system is infusing thedrug. The rate of delivery of the drug is provided to the AIM 180 as aresult of monitoring each infusion pump or channel. These feedbacksignals, which indicate the actual delivery rate of the drug, allows thePK model to compensate for an imperfect pump response to a requestedchange in the rate of drug delivery, and to compensate for alarm-causeddelays, and other interruptions in the delivery of the drug to apatient. The actual delivery rate also enables a more accurate drugconcentration prediction to be achieved, since a pump operations modulemay not deliver a drug at the rate it was commanded to by the advancedPK model programming 268. Furthermore, when the user selectivelyoperates a pump operations module under manual control, the PKsimulation 256 uses the drug rate delivery information to continue totrack and predict the drug concentration (either or both blood plasmaand effect compartment), even though it is not controlling that rate.This feature enables the predicted rate and historical rate to bedisplayed to the user for each drug administered, at any time, includingduring manual control of drug delivery and after the delivery of a drugis interrupted or even terminated.

Although the switch 260, first position 262, second position 266, manualcontrol 264, and Upload PK Programming 268 are shown as single items,they may include separate items for each individual pump operationsmodule. As an example, the switch 260 may actually represent threeswitches, one for each pump operations module, and the same is true forother items, such as the first position 262 and the second position 266.

The specific drug that is to be administered by one of the drug channels250, 252, or 254 could be identified with an entry by the user on akeypad or on the touch screen 182 of the user interface (FIG. 5).However, to simplify identification of the drugs to be infused, a barcode reader (not shown) can be used to scan a drug identification barcode that is affixed to each of the drug vials. Bar code readers arewell known and may comprise a fixed scanner that is positioned adjacenteach drug vial, or alternatively, may comprise a hand-held wand thatincludes an optical scanner that is moved to the drug vial to read thebar code. The AIM 180 may store or have access to drug libraries 192listing specific drugs commonly delivered to a patient by themulti-channel drug delivery system and their PK model data, so that oncethe bar code on a drug vial has been scanned, the AIM 180 can determinewhether the drug has been recognized as one of those for which data arestored. If PK control data are not stored for a drug, that drug cannotbe administered under the PK model control in the preferred embodiment;however, it is contemplated that the required data might then be enteredby the user on the touch screen 182 or a key pad 186.

The pump operating system of the pump operations module is programmed tomonitor the pump operations and to deliver basic rate/deliverytime/total dose programming. The pump operations module will alarm inthe situation where pump operation is not functioning properly. The pumpoperations will run each rate/time/volume instruction in the orderentered into the buffer memory. If all of the buffered (batch of)instructions have been completed, this is potentially an alarmcondition. Therefore, an alarm to signal completion of the delivery willactivate. As mentioned above, the AIM is used to program more advancedpump instructions. Delayed delivery starts, bolus deliveries, andvarious algorithms used in many drug delivery protocols including TCI,as well as other advanced delivery patterns or techniques to makemedications more effective for patients. The AIM contains the druglibrary, programming error checks, and other enhanced features. The druglibrary, advanced programming options and error checks are all in theAIM. The approved programming is then sent to the pump operations moduleas a batch of operations, each being defined as a simple rate/time/totaldose step.

The user interface on the pump operations module supports only thesebase functions of the pump; i.e., rate and VTBI. This pump operationsmodule user interface is a default if the advance programming uploadedto the pump operations module buffer is off line or not operating.However, the pump must be stopped to enter the base programmingparameters. The pump operations module stores in a buffer the scheduleddrug delivery parameters uploaded from the AIM. As each step of theuploaded buffer-stored delivery program is completed, the pump processoraccesses the buffer and the next delivery instruction is started.Therefore, the pump operation never is in competition with the userinterface.

It will be seen from the above, that the advanced delivery program isexecuted only by the operations module and is not executed by theadvanced interface module with the pump being controlled thereby. Thus,should the advanced interface module crash or be rendered unusableduring the execution of an advanced medication delivery program by apump operations unit, that crash will have no effect whatsoever ondelivery of the medication to a patient under that advanced deliveryprogram. Therefore, this failure mode, which comprises a major problemwith existing systems, has been removed from systems and methods inaccordance with the invention.

In the above detailed description, well-known devices, methods,procedures, and individual components have not been described in detailso as not to obscure aspects of the present invention. Those skilled inthe art will understand those devices, methods, procedures, andindividual components without further details being provided here.Moreover, while the embodiments disclosed above are described for use ina healthcare facility environment, it will be understood that the systemand method may be useful in other environments as well, such asoutpatient clinics and other environments where care is delivered to apatient.

In a further feature, active interaction with the AIM may beaccomplished by accessing the AIM remotely with commonly acceptedelectronic communication methods including but not limited tocommunication cables, Wi-Fi, mobile devices, with permission to accessthe facility's IT (information technology) network. The significance ofthe AIM function is to collect the information required to alter thedelivery instructions of the pump operations. As controlled with directhuman interface with the AIM, the information collected from the remotesource is stored and confirmed prior to initiating communication withthe pump operation (to stop pumping, for deleting and replacing bufferstorage with the new instructions). The ability for electronic devicesincluding medical devices to provide these details has been on themarket for years. What is not on the market is the AIM with the abilityto accept rapid communication from other electronic sources without therisk of creating an alarm condition which stops the delivery of thepump.

The invention disclosed here permits great flexibility in altering theprogramming of the medication delivery device, yet retains the absoluteautonomous operation of the delivery device. The invention disclosedhere permits great flexibility in altering the programming of themedication delivery device yet retains the absolute autonomous operationof the delivery device. Any authorized for alteration of pump deliverymay be programmed into the AIM and the order can be revised there.Therefore, any authorized communication human or remote electronicsource may then indicate to the AIM to upload this revised program intothe buffer memory 120 of the delivery device immediately. The AIM sendsa STOP signal to the user interface, a clear buffer signal to the userinterface, and then uploads the revised program into the buffer memory.When the base function program detects that a complete advanced deliveryprogram (in this case a revised one) has been loaded into the buffermemory, the integral local processor 122 begins executing the revisedprogram autonomously.

To reiterate briefly, the AIM may be located in the same housing as thedelivery device or may be located remotely from the delivery device. Forexample, the AIM may be located in a “cloud” based server. As is knownto those of skill in the art, “in the cloud” means storing and accessingdata and programs over the Internet instead of with the local computer'shard drive. It implies using a software service that is remotelylocated. Using a software service replaces the need to install softwareand/or hardware on the local computer. The cloud computer and softwaremay be in a different location but is delivered through the Internet.This greatly facilitates patient treatment using the subject system andmethod. The physician or HCP may be presently located in a differentlocation from the patient but can easily create and load the revisedtreatment program in the delivery device.

Continuously monitoring a patient's vital signs is routinely performedin many cases including critical care cases. Data from continuouslymonitoring a patient's vital signs also may be sent to a secure locationin the cloud where those who have authorized access can view it. As anexample, the patient's physician can view the critical care patient'svital signs through a cloud connection and can view the AIM in the cloudalso through a cloud connection. The AIM monitors the delivery ofmedication by the delivery device during execution of the advanceddelivery program. The physician or monitoring system can see thepatient's vital signs, monitor the execution of the program, revise theadvance delivery program at the AIM in the cloud, and can have thatrevised delivery program uploaded and running at computer at computerspeeds. In one embodiment, the AIM provides the ability to send a STOPsignal by itself through the user interface so that continued operationof the delivery device will not harm the patient while the revisedadvanced delivery program is being written to the buffer memory.

It should be noted that the basic principles of the invention areobserved even when a revised program is loaded into the delivery device70. That is, the delivery device operates autonomously and will notbegin execution of an advanced delivery program until the completeprogram is loaded into the buffer memory of the delivery device. Theinventive system and method will not permit anyone to alter the advanceddelivery program as it is running. To alter treatment, the program mustbe stopped, the buffer memory cleared, and the new or revised programcompletely loaded into the buffer memory before the delivery device willbegin executing the program. In the alternative, the delivery device maybe put into manual mode and operated from the front panel as a basefunction level.

Further features and/or variations of the invention may be provided inaddition to those set forth herein. For example, the present inventionmay be directed to various combinations and subcombinations of thedisclosed features and/or combinations and subcombinations of severalfurther features disclosed below in the detailed description.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments and elements, but, to the contrary, is intended tocover various modifications, combinations of features, equivalentarrangements, and equivalent elements included within the spirit andscope of the appended claims.

We claim:
 1. System for the delivery of medication, the systemcomprising: a medical delivery operations module comprising a deliverymechanism having a base function of medication delivery at a selectabledelivery rate and a selectable delivery volume, the medical deliveryoperations module further comprising a user interface, a buffer memory,a communications system, an operations module processor, and a basefunction control program stored in a non-volatile memory that isconfigured, when accessed and executed, to program the operations moduleprocessor to control the operation of the delivery mechanism to performits base function, wherein the operations module processor is connectedto the user interface to receive program instructions to set deliveryrate and delivery volume at fixed values; wherein the communicationssystem is configured to receive an advanced medication delivery programfrom an advanced interface module and store the advanced medicationdelivery program in the buffer memory, wherein the advanced medicationdelivery program has a plurality of different values for at least one ofthe delivery rate and the delivery volume that vary with time; andwherein the base function control program also programs the operationsmodule processor to access the buffer memory and when an advancedmedication delivery program has been completely loaded into the buffermemory and a “start” instruction is received from the user interface, toexecute the advanced medication delivery program under which theoperations module processor automatically varies at least one of therate of delivery and volume of delivery values in accordance with theadvanced delivery program, and wherein the operations module processoris programmed to execute the advanced delivery program residing in thebuffer memory autonomously without being under real time control of, ordependent on, any remote processor or data source including a processorat the advanced interface module, or the user interface, except that theuser interface is usable to start and stop the operations moduleprocessor in running the advanced delivery program, but neither the userinterface nor any other control or data device can be used to change theadvanced program while it is running; wherein the advanced interfacemodule is connected with the medical delivery operations module to stopexecution of the advanced delivery program, to clear the buffer memory,and to store a revised advanced delivery program in the buffer memory;and wherein when the operations module processor accesses the buffermemory and when the revised advanced medication delivery program hasbeen completely loaded into the buffer memory, and when a startinstruction is received, to execute the revised advanced medicationdelivery program.
 2. The medication delivery system of claim 1 whereinthe advanced medication delivery program and the revised advancedmedication delivery program comprise a sequence of varying base functionoperations that may be performed one at a time, with the operationsmodule processor being programmed to access the buffer memory toretrieve a base function operation after an earlier one has beenexecuted.
 3. The medication delivery system of claim 1 wherein theadvanced interface module (“AIM”) is configured to create advancedmedication delivery programs and comprises: an input device; a display;a medication delivery library containing delivery parameters andacceptable values for medications; an AIM processor programmed toprepare with reference to the library an advanced medication deliveryprogram and a revised advanced medication delivery program, includingvarying base functions; a nonvolatile memory in which is stored theadvanced delivery program and the revised advanced delivery program; andan AIM communication device to communicate the advanced medicationdelivery program and the revised advanced medication delivery program tothe communications system of the medical delivery operations module forstoring in the buffer memory of the medical delivery operations module.4. The medication delivery system of claim 3 wherein the display of theAIM includes a graphical touch screen, wherein the AIM processor isfurther programmed to display an acceptable range of values for aselected medication on the touch screen and accept a touch of a user toselect a particular value in the range, wherein that selected particularvalue is incorporated into an advanced medication delivery program. 5.The medication delivery system of claim 4 wherein the graphical touchscreen displays slide controls for parameters related to an accesseddelivery parameter from the medication library, and receives movement ofa cursor within the slide control to select a value for the medication.6. The system of claim 4 wherein the displayed range of values on theAIM for a selected medication includes absolute numbers at each end ofthe range plus a percentage value for the selected particular value inthe range.
 7. The system of claim 4 wherein the AIM display comprises apatient population switch that enables the display of drugs for thatpopulation as well as the limits for each drug specifically designed forthe selected population.
 8. The medication delivery system of claim 3wherein the medical delivery operations module is located in a housingand the advanced interface module is located in a second housing that isseparate from the housing of the medication delivery operations module.9. The medication delivery system of claim 3 wherein the medicaldelivery operations module is located in a housing and the advancedinterface module is located in the same housing.
 10. The medicationdelivery system of claim 3 wherein: the delivery mechanism of theoperations module comprises an infusion pump configured to delivermedication by pumping, wherein the base function of the pump operationsmodule is delivery rate and volume-to-be-infused (“VTBI”); and whereinthe advanced interface module processor is programmed to prepare anadvanced pumping program for the infusion pump comprising a sequence ofvarying at least one of delivery rate and/or VTBI values.
 11. The systemof claim 3 wherein an AIM is programmed to communicate advancedmedication delivery programs to a plurality of medical deliveryoperations modules with which it is simultaneously connected.
 12. Thesystem of claim 1 wherein the advanced delivery program comprises delaystarts and a series of rate and volume-to-be-infused commands.
 13. Thesystem of claim 1 wherein the medical delivery operations moduleprocessor is further programmed by the base function control program toprovide medication delivery data through the communications system to aPK simulation while the delivery mechanism is under manual userinterface control, to use the drug rate delivery information to continueto track and predict the drug concentration even though it is notcontrolling that rate.
 14. The system of claim 1 wherein the advanceddelivery program may be overridden at the user interface by pressing thestop key, at which time the user interface may be used to program atleast one of the delivery rate and delivery volume for manual operationof the delivery mechanism, and the user interface includes a continuekey that the user may press to return the delivery mechanism tooperation under the advanced delivery program.
 15. A method for thedelivery of medication, the method comprising: programming an operationsprocessor of a medication delivery operations module, wherein themedication delivery operations module includes a delivery mechanismhaving a base function of medication delivery at a selectable rate and aselectable volume, wherein the step of programming the operationsprocessor comprises programming the operations processor to set thedelivery rate and the delivery volume of the base function of thedelivery mechanism at fixed values; receiving an advanced medicationdelivery program from a source outside the medical delivery operationsmodule and storing the advanced medication delivery program in a buffermemory, wherein the advanced medication delivery program has a pluralityof different values that vary with time for at least one of the deliveryrate and the delivery volume; programming the operations processor toaccess the buffer memory for the existence of a complete advancedmedication delivery program, and if a complete advanced medicationdelivery program is found, to execute the advanced delivery programunder which the operations processor automatically varies at least oneof the rate of delivery and volume of delivery values in accordance withthe advanced delivery program autonomously without being under real timecontrol of, or dependent on, any remote processor or data source,including a processor at a source from which the advanced deliveryprogram came, or a user interface, except for starting and stopping theoperations processor in executing the advanced delivery program, butneither the user interface nor any other control or data device can beused to change the advanced program being executed while it is running;stopping execution of the advanced delivery program, clearing the buffermemory, and storing a revised advanced delivery program in the buffermemory; and when the revised advanced medication delivery program hasbeen completely loaded into the buffer memory, and when a startinstruction is received, executing the revised advanced medicationdelivery program.
 16. The medication delivery method of claim 15 whereinthe step of programming the operations processor further comprisesprogramming the operations processor to override execution of theadvanced medication delivery program upon receiving a STOP signal from auser interface of the operations module.
 17. The medication deliverymethod of claim 11 further comprising: creating the advanced medicationdelivery program in an advanced program processor that is part of anadvanced interface module (“AIM”), the advanced program processor beingseparate from the operations processor; wherein creating the advanceddelivery program comprises assembling a sequence of varying basefunction operations.
 18. The medication delivery method of claim 15wherein the step of creating an advanced medication delivery program inan advanced program processor comprises creating the advanced medicationdelivery program in an advanced program processor of the AIM wherein theAIM and the medication delivery operations module are located in a samehousing.
 19. The medication delivery method of claim 13 wherein the stepof creating the advanced delivery program by the advanced programprocessor further comprises programming the advanced program processorto communicate advanced medication delivery programs to a plurality ofmedical delivery operations modules with which it is simultaneouslyconnected.
 20. The medication delivery method of claim 15 furthercomprising programming the operations processor to provide medicationdelivery data through the communications system to a PK simulation whilethe delivery mechanism is under manual user interface control, to usethe drug rate delivery information to continue to track and predict thedrug concentration even though it is not controlling that rate.